A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement

一种用于引导外周中心静脉置管 (PICC) 导管置入的新型低成本设备

• 批准号: 9919215
• 负责人: Daniel Rogers Burnett
• 金额: $ 91.51万
• 依托单位: PICCOLO MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9919215
• 关键词: Address; Adopted; Adoption; Adult; Adverse event; Affect; Age; Algorithms; American; Anatomy; Area Under Curve; Arrhythmia; Automobile Driving; Blinded; Blood Vessels; Blood flow; Cardiac; Catheters; Characteristics; Clinic; Clinical; Clinical Research; Critical Illness; Data; Detection; Devices; Direct Costs; Distal; EKG P Wave; Electrocardiogram; Excision; Family suidae; Funding; Future; Goals; Head; Heart Atrium; Heart Valves; Infusion procedures; Intervention; Intravenous; Lead; Life; Location; Measures; Medical; Modeling; Multi-Institutional Clinical Trial; Myocardial; Navigation System; Nurses; Patients; Perforation; Performance; Peripheral; Phase; Pneumothorax; Positioning Attribute; Procedures; Quality of Care; Radiation exposure; Randomized; Real-Time Systems; Receiver Operating Characteristics; Research; Resolution; Right atrial structure; Risk; Roentgen Rays; Savings; Serious Adverse Event; Signal Transduction; Superior vena cava structure; System; Technology; Thermodilution; Thoracic Radiography; Thrombus; Time; Training; United States; Venous system; Work; base; blind; cohort; cost; cost effective; follow-up; heart rhythm; hemodynamics; improved; in vivo; innovation; machine learning algorithm; novel; point of care; pre-clinical; radiologist; sensor

Abstract In the United States alone, more than three million peripherally inserted central catheters (PICCs) are placed each year to provide IV therapies, where navigation through the venous system is typically performed blind, or without navigation guidance. Improper PICC placement is relatively common, is costly, and has serious complications for critically-ill patients. Unfortunately, under blind placement 30-55% of PICC tips are not optimally placed on the first attempt and require repositioning, which has an average direct cost of $223 per patient and often necessitates the removal and reinsertion of the catheter line that carries a 4-6% risk of pneumothorax. Moreover, approximately 17% of these improperly positioned PICCs are placed into the right atrium, which is associated with a multitude of life-threatening complications. Improper placement of PICCs also often requires referral to an interventional radiologist for fluoroscopic-guided central line placement, which is expensive ($1,000) and requires more radiation exposure for the patient. Not surprisingly, over half of all PICCs are administered to patients over the age of 60. Therefore, safe and accurate PICC placement is critical for providing high-quality care to older Americans. Despite serious adverse events associated with blind placement of PICC lines, current vascular access systems have not been widely adopted. The Teleflex ARROW® G4 VPS and the Bard Sherlock 3CG® TCS are PICC guidance systems that employ ECG for positioning the PICC tip into the correct location: the region that includes the lower superior vena cava (SVC) and cavoatrial junction (CAJ). While these procedures often limit the need for a confirmatory X-ray, they have poor and variable successful placement rates (44-84%), are 30-70% more expensive than standard PICCs, require skilled staff, and have significantly longer procedure times as compared to standard, blind PICC placement. Additionally, these guidance systems rely on the use of ECG, which is ineffective for patients with cardiac arrhythmias, a condition that affects approximately 16% of all patients requiring a PICC line. To address the need for accurate, safe, and cost- effective PICC placement, Piccolo Medical has developed the Smart PICC™ system, a point-of-care catheter system that uses unique hemodynamic signatures of different vascular regions for real-time vascular access guidance into the SVC/CAJ. The goals of this Phase II proposal are to validate the accuracy of the Piccolo Smart PICC™ for navigation and placement of a PICC tip into the SVC or CAJ for adult patients with and without cardiac arrhythmias. First, we will verify the sensitivity of the Smart PICC™ system algorithm to identify correct PICC placement in adult patients with both normal and altered cardiac rhythms (Aim 1). Second, we will compare the accuracy of the Smart PICC™ system to the most widely used catheter navigation system (BD’s Sherlock 3CG® TCS) in a head-to-head superiority study (Aim 2).The data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within ~2.5 years of the funding of this proposal.

摘要 仅在美国，就有300多万根经外周插入的中心静脉导管(PIC) 每年提供静脉疗法，其中通过静脉系统的导航通常是盲目进行的，或者 没有导航导航。PICC放置不当是比较常见的，代价高昂，而且严重 危重病人的并发症。不幸的是，在盲目安置下，30%-55%的PICC提示并不是最佳的 在第一次尝试时放置并需要重新定位，每个患者的平均直接成本为223美元 通常需要拔除并重新插入导管管路，该导管管路有4-6%的气胸风险。 此外，这些位置不当的PICC中，约有17%被放置在右心房，即右心房。 与多种危及生命的并发症有关。不适当地放置PIC还常常需要 转介到介入放射科医生进行透视引导的中心线放置，这是昂贵的 (1,000美元)，并要求患者暴露在更多的辐射中。不足为奇的是，超过一半的PIC 适用于60岁以上的患者。因此，安全和准确的PICC放置对于提供 为美国老年人提供高质量的护理。尽管与盲目放置PICC相关的严重不良事件 线，目前的血管通路系统还没有被广泛采用。Teleflex Arrow®G4 VPS和 Bard Sherlock 3CG®TCS是PICC引导系统，使用心电图将PICC尖端定位到 正确位置：包括下腔静脉(SVC)和腔静脉交界处(CAJ)的区域。而当 这些程序通常限制了对确认性X光的需求，它们的成功率很差，而且不稳定 费率(44%-84%)，比标准PICC贵30%-70%，需要熟练的员工，而且 与标准的、盲目放置PICC相比，操作时间更长。此外，这些制导系统 依赖于心电图的使用，这对心律失常患者无效，这是一种影响 大约16%的患者需要PICC管路。为了满足对准确、安全和成本的需求- 有效地放置PICC，Piccolo Medical开发了智能PICC™系统，这是一种护理点导管 使用不同血管区域的独特血流动力学特征进行实时血管访问的系统 向SVC/CAJ提供指导。此第二阶段提案的目标是验证Piccolo Smart PICC™用于导航并将PICC尖端放置到上腔静脉或颈动脉，适用于患有和不患有PICC的成人患者 心律失常。首先，我们将验证智能人保™系统算法的敏感度识别的正确性 在心律正常和心律改变的成人患者中放置PICC(目标1)。第二，我们将比较 Smart PICC™系统与最广泛使用的导管导航系统(BD的《神探夏洛克》)的准确性 3CG®TCS)进行了面对面的优势研究(AIM 2)。获得的数据将支持FDA 510(K)审批 并将使我们能够在该提案获得资金后约2.5年内将该系统商业化。